MAUDE Adverse Event Report: TENSCARE LTD. TENSCARE VAGINAL STIMULATOR; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Device Problem Product Quality Problem (1506)

Patient Problem Injury (2348)

Event Date 06/26/2019

Event Type  Injury  

Event Description

I bought a pelvic stimulator in (b)(6) 2019.By (b)(6) my 26 yr old episiotomy was tearing.By (b)(6) 2019 i needed surgery to repair it.Did not realize it was causing the damage so i began using it again in (b)(6).By (b)(6) i was having surgical breakdown.Now, i need a 2nd surgery to repair it again.Date the person first started taking or using the product: (b)(6) 2019.Supposed to strengthen pelvic floor.

• Brand Name: TENSCARE VAGINAL STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): TENSCARE LTD.
• MDR Report Key: 10395964
• MDR Text Key: 202720913
• Report Number: MW5096007
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 86